FDA Drug Recalls

Recalls / Class II

Class IID-0818-2020

Product

Tadalafil 20 mg Troche

Affected lot / code info
Lots: 61137:42 Use by: 03/08/2020; 61324:99 Use by: 04/04/2020; 60856:42 Use by: 02/02/2020

Why it was recalled

Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.

Recalling firm

Firm
MPRX, Inc. dba Medical Park Pharmacy
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
8230 Elmbrook Dr Ste 600b, N/A, Dallas, Texas 75247-4144

Distribution

Quantity
9 bottles
Distribution pattern
TX

Timeline

Recall initiated
2019-12-18
FDA classified
2020-01-29
Posted by FDA
2020-02-05
Terminated
2022-12-13
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0818-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.